JD Supra

Real-World Evidence: Non-Interventional Studies in Support of Substantial Evidence of Effectiveness

The US Food and Drug Administration (FDA) issued draft guidance, providing recommendations to sponsors who are considering submitting a non-interventional study (i.e., an observational study) to FDA ...
JD Supra

FDA advises on RWE non-interventional study use as evidence of effectiveness or safety

Today, the U.S. Food and Drug Administration (FDA) published the draft guidance “Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products,” which ...
ascopubs.org

CaboCombo: A prospective international non-interventional study of first-line cabozantinib plus nivolumab for the treatment of patients with advanced renal cell carcinoma.

Outcomes Database to Prospectively Assess the Changing Therapy Landscape in Renal Cell Carcinoma (ODYSSEY RCC). This is an ASCO Meeting Abstract from the 2023 ASCO Genitourinary Cancers Symposium.
EurekAlert!

Early study suggests a new, injectable gel may greatly reduce chronic low back pain

FAIRFAX, Va. (June 8, 2022)—An experimental formulation of a hydrogel, injected into spinal discs, proved safe and effective in substantially relieving chronic low back pain caused by degenerative ...
Oklahoma's News

Burning Rock Announces the Launch of China’s First Prospective Interventional Validation Study on Multi-Cancer Early Detection - the PREVENT Study

CHENGDU, China, June 30, 2022 (GLOBE NEWSWIRE) -- Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”), a company focused on the application of next generation sequencing (NGS) ...